Uncertainty whether blood substitute study affects Tech

Published: Thursday, May 01, 2008

MARLENA HARTZ

Authors of a new study that exposes health risks associated with human blood substitutes and makers and marketers of a substitute that has Texas Tech ties disagree on whether the study applies to the Tech-born product, HemoTech.

It was not one of the five blood substitutes examined for the study, which found the substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warnings.

"It does seem like our conclusions would apply to this product because it's hemoglobin taken out of red blood cells and manipulated chemically," said Dr. Peter Lurie, one of the study's authors and the deputy director of the Public Citizen's Health Research Group.

Lurie and another author stressed they had not studied HemoTech.

Those with close ties to HemoTech, which is made from cow blood and has been touted as the first safe blood substitute, said it is too different to be compared to the substitutes examined in the study, which was written by scientists with the NIH Clinical Center and advocates with the watchdog group Public Citizen.

"The other investigators are always going to try to make it look as though everybody's in the same ballpark. But we are not. We are not in the same ballpark because of the way (our) hemoglobin is ... combined with other products," said Dr. Bernhard Mittemeyer, the former interim president of the Tech Health Sciences Center and a member of the board of directors of HemoBioTech Inc., the company that markets HemoTech.

The Journal of the American Medical Association published the risks study online on Monday.

It sites a 30 percent higher risk of death overall for patients who received transfusions using blood substitutes developed by the five different companies; 164 of those patients died. Among those who received ordinary blood products or saline transfusions, 123 died, according to the study, which some blood substitute makers have described as flawed.

The risk of heart attack was nearly tripled in the groups receiving blood substitutes. There were 59 heart attacks in that group compared with 16 heart attacks in the group that didn't get the new products.

But HemoTech, which is under FDA review and was tested on African children almost two decades ago, is the potential answer to the problems that have plagued other blood substitutes for decades, according to its makers and marketers.

"I think that (the JAMA study) on the problems with the first-generation products could help us to commercialize our blood substitute faster," said Dr. Jan Simoni, one of two Tech Health Sciences Center researchers who invented HemoTech.

The relevant HemoTech ingredient is adenosine, a chemical naturally found in the human body with anti-inflammatory benefits that blocks the dangerous inflammatory affects of other blood substitutes, HemoTech associates said.

HemoTech was developed by Simoni, who works in Tech's department of surgery, and Dr. Mario Feola, who has retired from the university and is a HemoBioTech employee. It's being commercially developed by the Dallas-based company HemoBioTech, which also financially supports further research on the product.

Tech retains control over the future of the product, which is researched and manufactured in Lubbock, according to the company's Web site, www.hemobiotech.com.

Currently, the product is undergoing pre-clinical animal studies in preparation for more human clinical trials, Simoni told The Avalanche-Journal in an e-mail. The animal studies are necessary to obtain FDA permission for human clinical trials in the U.S., he wrote.

However, HemoBioTech has already taken steps to test the product on humans in India.

Currently, there are no approved blood substitutes or clinical studies of them in the United States. However, American companies are testing them on people in South Africa and seven European countries.

"It is highly unlikely, I'd say impossible, that any of these countries are aware of the risk," said study co-author Dr. Sidney Wolfe of Public Citizen.

Feola, Simoni and other researchers tested their blood substitute in 1991 on nine children from Zaire, Africa with sickle cell anemia.

The children were monitored for three months after being given the substitute and showed health improvements, according to a HemoBioTech news release.

But there appears to have been no control group in the small study, which undermines the results, said the JAMA study authors. HemoTech associates said the results are significant because positive rather than adverse side effects were discovered in the patients, who they said desperately needed the blood substitute.

HemoBioTech has submitted the results of that study to an Indian regulatory agency which will determine if HemoTech is safe to test on humans, said Dr. Arthur Bollon, the CEO of the company.

The company could make billions from middle-class Indians if the product was sold in the country, where the prevalence of AIDS is high and sick people are desperate for safe human blood alternatives, Bollon said.

"At this point," said the lead author of the JAMA study, Dr. Charles Natanson, of the National Institutes of Health Clinical Center, "the benefit of the doubt should go toward the patient, in one would have to prove a different toxicity level (than other products)."

Bollon said his product has and could be a boon for poor nations with crippled blood supply systems.

"There is a good probability that (HemoTech) will be safe.

"The potential advantage to third world countries of a product like this would be revolutionary," he said.